BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT +M PELVIC FLOOR REPAIR

    MDR report key: 3100224 · Received May 8, 2013

    Report

    Report Number
    2210968-2013-05291
    Event Type
    Injury
    Date Received
    May 8, 2013
    Report Date
    April 19, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTP
    PMA / PMN Number
    K071512
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT STRESS URINARY INCONTINENCE AND HEMATURIA. IT WAS REPORTED THAT PATIENT UNDERWENT MESH REVISION/REMOVAL ON (B)(6) 2011 DUE TO BLADDER CALCULI, AND FOREIGN BODY IN BLADDER. (B)(4) ¿BLADDER CALCULI; FOREIGN BODY IN BLADDER.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE: THE PATIENT UNDERWENT MESH IMPLANTATION ON (B)(6) 2011 DUE TO POSTERIOR REPAIR. THE PATIENT THEN EXPERIENCED PAIN, EROSION, EXTRUSION, INFECTION, BLEEDING, DYSPAREUNIA, VAGINAL SCARRING, ORGAN PERFORATION, AND URINARY/ BOWEL PROBLEMS. IT WAS REPORTED THAT PATIENT UNDERWENT REMOVAL REVISION PROCEDURES ON (B)(6) 2009, (B)(6) 2011. (B)(4) ¿ DYSPAREUNIA; URINARY PROBLEMS; BOWEL PROBLEMS. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED ON (B)(6) 2011. IT WAS REPORTED THAT THE PATIENT UNDERWENT EXCISION OF MESH ON (B)(6) 2011 DUE TO MESH EROSION. NO ADDITIONAL INFORMATION WAS PROVIDED

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT CYSTOSCOPY AND ELECTROHYDRAULIC CYSTOLITHOLAPAXY OF BLADDER STONE, AND BILATERAL RETROGRADE PYELOGRAM ON (B)(6) 2011. IT WAS REPORTED THAT THE PATIENT UNDERWENT CYSTOSCOPY, AND CYBERWAND REMOVAL OF BLADDER CALCULI ON (B)(6) 2011.

    Description of Event or Problem · 1

    IT WAS ALSO REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2011 AND MESH WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201716 PROLIFT +M PELVIC FLOOR REPAIR MESH, SURGICAL, POLYMERIC OTP ETHICON, INC. NA 3468181

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention